IlluminOss Medical Receives ISO 13485 Certification
Company with Innovative Technology for the Minimally Invasive Treatment of
Bone Fractures Achieves Significant Milestone in CE Mark Approval Pathway
East Providence, RI – February 20, 2009 – IlluminOss Medical Inc., a medical
device company developing the innovative IlluminOss™ Photodynamic Bone
Stabilization System for orthopedic surgery, today announced that it had
received an ISO 13485 Certificate of Registration issued by BSI (British
Standards Institute). This certification indicates that IlluminOss has
implemented a quality system that conforms to the exacting International
Organization for Standardization (ISO) standards for medical devices and is one
of the key regulatory requirements for a CE Mark in the European Union as well
as other international markets.
ISO 13485 is an internationally recognized standardization system which defines
standards for the design, development, production and distribution of medical
devices. It ensures conformity with specified quality controls in the
development of safe and effective devices.
According to Bob Rabiner, Founder and President of IlluminOss Medical, “ISO
13485 certification represents a major milestone for IlluminOss and patients
worldwide. We believe that our minimally invasive technology will fundamentally
improve the treatment of hundreds of thousands of bone fractures by driving much
earlier restoration of functionality, improving the durability of orthopedic
repairs, decreasing pain and reducing scarring.”
About IlluminOss Medical Inc.
IlluminOss Medical is a privately held, early-stage medical device company
dedicated to the development of minimally invasive orthopedic systems for the
stabilization and treatment of bone fractures. The IlluminOss Photodynamic Bone
Stabilization System utilizes a photodynamic (light-curable) polymer system
intended to eliminate the need for traditional, inconvenient and painful methods
of bone fixation with external pins, plates and screws. The Company is currently
developing the IlluminOss Photodynamic Bone Stabilization System for small bones
such as fractures of the hands, wrists, clavicle and arms. It is anticipated
that the IlluminOss Photodynamic Bone Stabilization System will also have
applications in the spine and long bones.
Founded in 2007, IlluminOss is headquartered in East Providence, RI. For more
information about IlluminOss Medical, please visit
www.illuminoss.com.
